Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data Sheet
File ref: TT50-8593
Trade NameDose FormStrengthIdentifier
NaltraccordFilm coated tablet50 mg
SponsorApplication dateRegistration situationClassification
Teva Pharma (New Zealand) Limited
P O Box 128 244
Remuera
Auckland 1541
21/6/2010Consent given
Approval date: 2/12/2010
Prescription
Reference product: ReVia Film coated tablet 50 mg

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Naltrexone hydrochloride 50 mgSanofi Chimie
Route D'Avignon
Aramon F-30390
France
 Excipient 
 Colloidal silicon dioxide
 Crospovidone
 Lactose monohydrate
 Magnesium stearate
 Microcrystalline cellulose
 Opadry yellow YS-1-6378G

Production

Manufacturing stepManufacturer
Finished Product TestingIntas Pharmaceuticals Ltd
Plot Nos. 457-458 Sarkhej Bavla Highway
Matoda
Sanand, Ahmedabad
Gujarat 382 210
India
Manufacture of Final Dose FormIntas Pharmaceuticals Ltd
Plot Nos. 457-458 Sarkhej Bavla Highway
Matoda
Sanand, Ahmedabad
Gujarat 382 210
India
PackingIntas Pharmaceuticals Ltd
Plot Nos. 457-458 Sarkhej Bavla Highway
Matoda
Sanand, Ahmedabad
Gujarat 382 210
India
NZ Site of Product ReleaseTeva Pharma (New Zealand) Limited
Level 14, 41 Shortland Street
Auckland 1010

Packaging

PackageContentsShelf Life
Blister pack, PVC/PE/Aclar-Al or Al-Al14 tablets36 months from date of manufacture stored at or below 25°C
Blister pack, PVC/PE/Aclar-Al or Al-Al28 tablets36 months from date of manufacture stored at or below 25°C
Blister pack, PVC/PE/Aclar-Al or Al-Al30 tablets36 months from date of manufacture stored at or below 25°C

Indications

Naltraccord is indicated for use within a comprehensive treatment programme for alcohol dependence.

Naltraccord is also indicated as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
12/12/2019Changed Medicine NotificationActive ingredient manufacturing process - Grade 1; Active ingredient manufacturing process - Grade 3Granted 14/1/202031/12/2019 
21/6/2010New Intermediate-risk Medicine ApplicationAbridged new intermediate-risk prescription medicineGranted 2/12/201024/6/2010 
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